Evaluation of Tolerability of Adjuvant Cisplatin/Docetaxel in Completely Resected Stage IB/II Non-Small Cell Lung Cancer
TOLEDO
Randomized Phase II Study Evaluating The Tolerability Of Adjuvant Docetaxel-based Chemotherapy For Completely Resected Stage IB-II Non-Small Cell Lung Cancer (NSCLC): Toledo Trial
2 other identifiers
interventional
99
1 country
3
Brief Summary
The aim of this study is to evaluate the tolerability (in terms of drug delivery and toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely resected stage IB-II Non-Small Cell Lung Cancer. To avoid a selection bias, eligible patients will be randomised to receive cisplatin/docetaxel or cisplatin/vinorelbine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Dec 2005
Typical duration for phase_2 nonsmall-cell-lung-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 12, 2007
CompletedFirst Posted
Study publicly available on registry
February 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedNovember 30, 2010
November 1, 2010
4.8 years
February 12, 2007
November 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Success of delivery treatment; data collected during chemotherapy treatment
Toxicity (occurrence of any grade 4 toxicity); data collected at the end of each cycle
Secondary Outcomes (2)
Overall toxicity
Progression free survival and overall survival
Interventions
Eligibility Criteria
You may qualify if:
- completely resected pathological stage IB or II NSCLC
- adequate haematological, renal and liver function and condition
You may not qualify if:
- previous chemo or radiotherapy for NSCLC
- bronchoalveolar cell subtype
- second active primary malignancy or serious concomitant medical disease
- difficulties with adequate follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Antwerplead
- Universiteit Antwerpencollaborator
- Sanoficollaborator
Study Sites (3)
ZNA Middelheim
Antwerp, Antwerp, 2020, Belgium
University Hospital Antwerp
Edegem, Antwerp, 2650, Belgium
St Augustinus ziekenhuis
Wilrijk, Antwerp, 2610, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul R. Germonpre, MD PhD
Universiteit Antwerpen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 12, 2007
First Posted
February 13, 2007
Study Start
December 1, 2005
Primary Completion
September 1, 2010
Study Completion
November 1, 2010
Last Updated
November 30, 2010
Record last verified: 2010-11